Procalcitonin for Predicting Serious Bacterial Infection in Infants Less Than 3 Months

Fever Clinical Trial

— PRONOUR  

Official title:

Usefulness of Serum Procalcitonin for Predicting Serious Bacterial Infection in Febrile Infants Less Than 3 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00800488
• Other study ID #: AOR 06 047
• Status: Completed
• Phase: N/A
• First received: November 24, 2008
• Last updated: July 25, 2014
• Start date: October 2008
• Est. completion date: April 2011

Study information

• Verified date: April 2011
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The primary objective is to study the value of serum procalcitonin as a predictive marker for severe bacterial infection in febrile infants.

2200 febrile infants aged less than 3 months will prospectively be included. All infants will have a measure of Procalcitonin concentrations. Comparison of the mean value of Procalcitonin concentration in infants with and without serious Bacterial infection.

Evaluation of the area under the ROC for Procalcitonin concentration.

Description:

Serious bacterial infections are often difficult to detect in infant with fever without source. Procalcitonin is a better blood marker of infection than White blood cell count and possibly than C-reactive protein. This could lead to a reduction in antibiotic prescription. Our objective is to evaluate the impact of Procalcitonin result on antibiotic prescription in children 1 to 3 month old with fever without source and our hypothesis is that it will lower the antibiotic prescription rate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2209
• Est. completion date: April 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Months

Eligibility

Inclusion Criteria:

• Infant older than 7 days old and less than 3 months old.

• Fever (defined by a rectal temperature greater than or equal to 38°C)

• Emergency consultation

Exclusion Criteria:

• Infants with a previously identified immunodeficiency or chronic disease,

• Antibiotic treatment within the previous 48 hours

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bacterial Infection
• Bacterial Infections
• Communicable Diseases
• Fever
• Infection

Locations

Country	Name	City	State
France	Pediatric Emergency Depatment - Hôpital Antoine Béclère	Clamart	Hauts-de-Seine

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the ROC curve of the serum Procalcitonin concentration in the diagnosis of serious bacterial infections		At the day of emergency consultation for fever	No
Secondary	Diagnostic value (sensibility and specificity) of clinical examination versus procalcitonin		At the day of emergency consultation for fever	No
Secondary	Diagnostic value (sensibility and specificity) of complete blood count versus procalcitonin		At the day of emergency consultation for fever	No
Secondary	Diagnostic value (sensibility and specificity) of CRP versus procalcitonin		At the day of emergency consultation for fever	No